MS&T Process Engineer

MS&T Process Engineer

Status: Full Time Employee

Overview: The Manufacturing Science and Technology (MS&T) Process Engineer will lead technology transfers from internal and external sources. Develop batch records, applicable procedures, technical specifications and provide required process support for sterile manufacturing. Monitor processes, analyze data, and prepare product summaries, evaluations and reports. Support release activities, including deviation assessment and change controls. Provide guidance and mentorship to team members. Collaborate with internal teams and customers to ensure successful project execution. Comply with all regulatory, safety, and sustainability requirements.

The Senior MS&T Engineer identifies opportunities and implements systems that improve Operations Systems. Responsible for monitoring and controlling of continuous process improvements of manufacturing operations. Deliver performance excellence through a team and collaborative approach and align with the client’s philosophy and operating style. This position reports to the Manager of MS&T.

Responsibilities:

• Write scientific documents to support justification for process scale-up, technology transfer, and/or equipment changes. Provides technical review and/or approval of contracted and internal formulation and development work for products and technologies. Develop and implement methods and procedures for inspecting, testing and evaluation of products for acceptability.
• Lead process validation batches by writing and executing process performance qualification or process validation protocols and support Operations during execution. Perform process simulations and troubleshooting issues. Plan, lead, and execute complex cross functional projects impacting Operations and other areas of the business.
• Support Operations team in the development of technical specifications for materials and components required for Operations processing.
• Support Validation Team in commissioning, qualification and/or validation for facilities, utilities, equipment and processes. Support commissioning, installation, operational, performance qualifications, cleaning validations, Media Fills, Airflow Studies, as required to support sterile manufacturing.
• Assess existing processes and provide ideas to reduce costs, improve production rates and enhance quality and compliance. Perform optimization tests and risk assessments. Develop standardized operating instructions for the upgrades process. Lead continuous improvement activities of productivity, quality, cost, cycle time and yield of raw material.
• Lead efforts to maintain and improve quality and compliance of existing operations, processes, and products. Develop routines and best practices to ensure product quality and compliance. Address operational issues (e.g., Deviations, CAPA) quickly and effectively. Utilize root cause analysis methods and statistical tools to resolve operational processing issues. Use statistical methods to determine in-control/out-of-control processes.

Qualifications:

Required Skills/Abilities:

• Proven project leadership / management skills required. Excellent verbal, written and interpersonal skills. Proficiency with MS Word, MS Excel, MS PowerPoint, MS Project, and MS Visio required.
• Lean Manufacturing and/or process controls experience a plus. Advanced technical skills; analytical thinker. Must be well organized, self-directed, and a team player.
• Familiarity with state health and safety regulations. Must be resourceful with a strong customer-service orientation and commitment to providing timely and quality solutions to customer issues. Must be detail-oriented, with strong analytical and problem-solving skills to effectively research, troubleshoot and solve challenging problems involving integrated systems.
• Must possess a strong understanding of business processes related to pharmaceutical corporate activities. Strong integrity and work ethic are critical . Demonstrated ability to deal with confidential information.

Education/Experience:

• Bachelor’s degree in Engineering/ Biology/ Chemistry/or related science
• A minimum of 10 years of experience in Manufacturing, Engineering, Commissioning Qualification and Validation, Process Design Optimization or Development, Technology Transfer Projects in the pharmaceutical industry
• Experience with process simulations, Manufacturing Start-up and Scale-up from Research & Development

Physical Requirements:

• Must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function
• May be required to perform tasks essential to the job function in areas that require the use of personal protective equipment

Training:

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
• Must successfully complete all material handling training/verification as part of ongoing training.